Chronic Plaque-type Psoriasis
Conditions
Keywords
Moderate to severe chronic plaque-type psoriasis, AIN457, dermatology
Brief summary
The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).
Interventions
DRUGAIN457
DRUGPlacebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization At randomization, moderate to severe psoriasis as defined by: * PASI score of 12 or greater and, * IGA score of 3 or greater and, * Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by topical treatment.
Exclusion criteria
* Forms of psoriasis other than chronic plaque-type * Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization * Previous exposure to AIN457 * Ongoing use of prohibited psoriasis treatments / medications and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to * Known immunosuppression (e.g., AIDS) at screening and / or randomization * History or evidence of active tuberculosis at screening * Active systemic infections (other than common cold) * History or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years. * Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study * Any clinically significant abnormal laboratory tests at randomization, that in the judgment of the investigator prevents the patient from participating in the study * Inability or unwillingness to undergo repeated venipuntures * History or evidence of drug or alcohol abuse * Pregnant or nursing (lactating) women Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13 | week 13 | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37 | IGA treatment response is defined as achievement of IGA 0 (clear) or 1 (almost clear) and improvement of at least 2 points on the IGA scale compare with baseline. |
| Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37 | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). |
| To Assess the Time to Relapse | 37 weeks | Relapse is defined as the loss of at least 50% of the maximum PASI change from baseline achieved at any time before that visit and analyzed only for the active treatment groups. |
Countries
Canada, Estonia, Iceland, Japan, Latvia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AIN457 1x25mg AIN457 25mg Subcutaneously as a single dose | 29 |
| AIN457 3x25mg AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | 26 |
| AIN457 3x75mg AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | 21 |
| AIN457 3x150mg AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | 27 |
| Placebo Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) | 22 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | administrative problems | 1 | 1 | 0 | 2 | 1 |
| Overall Study | Adverse Event | 1 | 1 | 0 | 1 | 0 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 | 1 | 2 | 0 |
| Overall Study | unsatisfactory therapeutic effect | 4 | 6 | 2 | 0 | 6 |
| Overall Study | Withdrawal by Subject | 8 | 2 | 1 | 2 | 3 |
Baseline characteristics
| Characteristic | AIN457 1x25mg | AIN457 3x25mg | AIN457 3x75mg | AIN457 3x150mg | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 46.1 years STANDARD_DEVIATION 12.65 | 46.3 years STANDARD_DEVIATION 13.43 | 45.8 years STANDARD_DEVIATION 12.36 | 45.4 years STANDARD_DEVIATION 11.64 | 45.9 years STANDARD_DEVIATION 10.88 | 45.9 years STANDARD_DEVIATION 12.07 |
| Sex: Female, Male Female | 9 Participants | 4 Participants | 7 Participants | 6 Participants | 8 Participants | 34 Participants |
| Sex: Female, Male Male | 20 Participants | 22 Participants | 14 Participants | 21 Participants | 14 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 29 | 11 / 26 | 10 / 21 | 16 / 27 | 8 / 22 |
| serious Total, serious adverse events | 0 / 29 | 2 / 26 | 1 / 21 | 0 / 27 | 2 / 22 |
Outcome results
Primary
Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Time frame: week 13
Population: The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 1x25mg | Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13 | 3.4 percentage of participants |
| AIN457 3x25mg | Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13 | 19.2 percentage of participants |
| AIN457 3x75mg | Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13 | 57.1 percentage of participants |
| AIN457 3x150mg | Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13 | 81.5 percentage of participants |
| Placebo | Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13 | 9.1 percentage of participants |
Secondary
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
Time frame: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37
Population: The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 13 PASI 50 | 17.2 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 9 PASI 90 | 0 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 29 PASI 50 | 17.2 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 33 PASI 75 | 3.4 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 13 PASI 75 | 3.4 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 25 PASI 75 | 0 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 13 PASI 90 | 0 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 37 PASI 75 | 3.4 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 17 PASI 50 | 20.7 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 3 PASI 75 | 0 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 2 PASI 90 | 0 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 33 PASI 50 | 10.3 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 17 PASI 75 | 6.9 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 25 PASI 90 | 0 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 17 PASI 90 | 0 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 25 PASI 50 | 13.8 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 21 PASI 50 | 13.8 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 3 PASI 90 | 0 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 29 PASI 90 | 0 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 2 PASI 50 | 3.4 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 5 PASI 50 | 10.3 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 3 PASI 50 | 3.4 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 37 PASI 50 | 17.2 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 5 PASI 75 | 0 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 21 PASI 90 | 0 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 5 PASI 90 | 0 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 9 PASI 50 | 10.3 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 29 PASI 75 | 0 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 37 PASI 90 | 0 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 33 PASI 90 | 0 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 9 PASI 75 | 3.4 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 2 PASI 75 | 0 Percentage of Participants |
| AIN457 1x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 21 PASI 75 | 0 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 3 PASI 90 | 0 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 13 PASI 50 | 57.7 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 33 PASI 90 | 0 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 21 PASI 90 | 15.4 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 37 PASI 50 | 30.8 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 9 PASI 50 | 38.5 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 13 PASI 75 | 19.2 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 29 PASI 50 | 46.2 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 5 PASI 50 | 15.4 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 37 PASI 75 | 19.2 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 2 PASI 75 | 0 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 13 PASI 90 | 7.7 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 25 PASI 90 | 11.5 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 2 PASI 50 | 7.7 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 33 PASI 50 | 34.6 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 33 PASI 75 | 19.2 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 17 PASI 50 | 53.8 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 9 PASI 90 | 3.8 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 5 PASI 75 | 7.7 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 29 PASI 75 | 15.4 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 25 PASI 75 | 19.2 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 17 PASI 75 | 26.9 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 3 PASI 75 | 0 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 2 PASI 90 | 0 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 21 PASI 75 | 23.1 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 9 PASI 75 | 11.5 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 17 PASI 90 | 15.4 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 5 PASI 90 | 0 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 3 PASI 50 | 7.7 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 21 PASI 50 | 50.0 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 25 PASI 50 | 50.0 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 37 PASI 90 | 3.8 Percentage of Participants |
| AIN457 3x25mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 29 PASI 90 | 7.7 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 33 PASI 75 | 23.8 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 21 PASI 75 | 38.1 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 21 PASI 90 | 9.5 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 29 PASI 75 | 23.8 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 25 PASI 50 | 57.1 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 25 PASI 75 | 33.3 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 25 PASI 90 | 19.0 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 3 PASI 50 | 23.8 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 29 PASI 50 | 52.4 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 3 PASI 75 | 0 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 37 PASI 90 | 9.5 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 37 PASI 50 | 47.6 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 3 PASI 90 | 0 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 5 PASI 50 | 28.6 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 5 PASI 75 | 4.8 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 2 PASI 50 | 4.8 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 33 PASI 90 | 9.5 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 5 PASI 90 | 0 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 9 PASI 50 | 52.4 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 9 PASI 75 | 33.3 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 9 PASI 90 | 9.5 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 13 PASI 50 | 81.0 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 2 PASI 75 | 0 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 13 PASI 75 | 57.1 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 33 PASI 50 | 47.6 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 13 PASI 90 | 19.0 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 37 PASI 75 | 19.0 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 17 PASI 50 | 76.2 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 17 PASI 75 | 42.9 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 29 PASI 90 | 14.3 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 17 PASI 90 | 9.5 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 21 PASI 50 | 57.1 Percentage of Participants |
| AIN457 3x75mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 2 PASI 90 | 0 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 29 PASI 50 | 85.2 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 17 PASI 90 | 44.4 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 2 PASI 50 | 11.1 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 2 PASI 75 | 0 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 2 PASI 90 | 0 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 3 PASI 50 | 18.5 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 3 PASI 75 | 0 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 3 PASI 90 | 0 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 5 PASI 50 | 48.1 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 5 PASI 75 | 14.8 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 5 PASI 90 | 3.7 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 9 PASI 50 | 85.2 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 9 PASI 75 | 66.7 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 9 PASI 90 | 14.8 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 13 PASI 50 | 85.2 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 13 PASI 75 | 81.5 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 13 PASI 90 | 51.9 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 17 PASI 50 | 85.2 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 17 PASI 75 | 81.5 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 21 PASI 50 | 85.2 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 21 PASI 75 | 77.8 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 21 PASI 90 | 37.0 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 25 PASI 50 | 85.2 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 25 PASI 75 | 70.4 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 25 PASI 90 | 29.6 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 29 PASI 75 | 59.3 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 29 PASI 90 | 22.2 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 33 PASI 50 | 77.8 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 33 PASI 75 | 55.6 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 33 PASI 90 | 18.5 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 37 PASI 50 | 63.0 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 37 PASI 75 | 25.9 Percentage of Participants |
| AIN457 3x150mg | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 37 PASI 90 | 11.1 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 21 PASI 50 | 31.8 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 17 PASI 75 | 13.6 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 2 PASI 75 | 0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 29 PASI 90 | 9.1 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 17 PASI 50 | 27.3 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 13 PASI 90 | 4.5 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 13 PASI 75 | 9.1 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 37 PASI 90 | 4.5 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 33 PASI 50 | 22.7 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 13 PASI 50 | 18.2 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 9 PASI 90 | 0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 9 PASI 75 | 9.1 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 37 PASI 75 | 4.5 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 33 PASI 75 | 4.5 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 9 PASI 50 | 13.6 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 5 PASI 90 | 0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 5 PASI 75 | 4.5 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 2 PASI 50 | 0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 33 PASI 90 | 4.5 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 5 PASI 50 | 4.5 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 3 PASI 90 | 0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 3 PASI 75 | 0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 17 PASI 90 | 0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 37 PASI 50 | 22.7 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 3 PASI 50 | 4.5 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 25 PASI 90 | 4.5 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 29 PASI 50 | 27.3 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 25 PASI 75 | 9.1 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 25 PASI 50 | 31.8 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 21 PASI 90 | 4.5 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 2 PASI 90 | 0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 29 PASI 75 | 13.6 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90) | Week 21 PASI 75 | 13.6 Percentage of Participants |
Secondary
Percentage of Participants With Investigator's Global Assessment (IGA) Response
IGA treatment response is defined as achievement of IGA 0 (clear) or 1 (almost clear) and improvement of at least 2 points on the IGA scale compare with baseline.
Time frame: Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37
Population: The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIN457 1x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 13 | 0 percentage of participants |
| AIN457 1x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 21 | 0 percentage of participants |
| AIN457 1x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 17 | 3.4 percentage of participants |
| AIN457 1x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 37 | 0 percentage of participants |
| AIN457 1x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 3 | 0 percentage of participants |
| AIN457 1x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 9 | 0 percentage of participants |
| AIN457 1x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 33 | 0 percentage of participants |
| AIN457 1x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 5 | 0 percentage of participants |
| AIN457 1x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 29 | 0 percentage of participants |
| AIN457 1x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 2 | 0 percentage of participants |
| AIN457 1x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 25 | 0 percentage of participants |
| AIN457 3x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 9 | 7.7 percentage of participants |
| AIN457 3x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 2 | 0 percentage of participants |
| AIN457 3x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 21 | 19.2 percentage of participants |
| AIN457 3x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 25 | 15.4 percentage of participants |
| AIN457 3x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 29 | 11.5 percentage of participants |
| AIN457 3x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 17 | 19.2 percentage of participants |
| AIN457 3x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 37 | 15.4 percentage of participants |
| AIN457 3x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 13 | 11.5 percentage of participants |
| AIN457 3x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 33 | 15.4 percentage of participants |
| AIN457 3x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 5 | 3.8 percentage of participants |
| AIN457 3x25mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 3 | 0 percentage of participants |
| AIN457 3x75mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 33 | 19.0 percentage of participants |
| AIN457 3x75mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 2 | 0 percentage of participants |
| AIN457 3x75mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 3 | 0 percentage of participants |
| AIN457 3x75mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 5 | 4.8 percentage of participants |
| AIN457 3x75mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 9 | 28.6 percentage of participants |
| AIN457 3x75mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 13 | 33.3 percentage of participants |
| AIN457 3x75mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 17 | 28.6 percentage of participants |
| AIN457 3x75mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 21 | 38.1 percentage of participants |
| AIN457 3x75mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 25 | 33.3 percentage of participants |
| AIN457 3x75mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 29 | 19.0 percentage of participants |
| AIN457 3x75mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 37 | 9.5 percentage of participants |
| AIN457 3x150mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 13 | 48.1 percentage of participants |
| AIN457 3x150mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 21 | 40.7 percentage of participants |
| AIN457 3x150mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 9 | 37 percentage of participants |
| AIN457 3x150mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 25 | 37 percentage of participants |
| AIN457 3x150mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 5 | 7.4 percentage of participants |
| AIN457 3x150mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 37 | 25.9 percentage of participants |
| AIN457 3x150mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 29 | 40.7 percentage of participants |
| AIN457 3x150mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 3 | 3.7 percentage of participants |
| AIN457 3x150mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 33 | 29.6 percentage of participants |
| AIN457 3x150mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 17 | 51.9 percentage of participants |
| AIN457 3x150mg | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 2 | 3.7 percentage of participants |
| Placebo | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 33 | 0 percentage of participants |
| Placebo | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 29 | 13.6 percentage of participants |
| Placebo | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 21 | 13.6 percentage of participants |
| Placebo | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 9 | 9.1 percentage of participants |
| Placebo | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 13 | 9.1 percentage of participants |
| Placebo | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 5 | 0 percentage of participants |
| Placebo | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 2 | 0 percentage of participants |
| Placebo | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 25 | 18.2 percentage of participants |
| Placebo | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 37 | 0 percentage of participants |
| Placebo | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 3 | 0 percentage of participants |
| Placebo | Percentage of Participants With Investigator's Global Assessment (IGA) Response | Week 17 | 9.1 percentage of participants |
Secondary
To Assess the Time to Relapse
Relapse is defined as the loss of at least 50% of the maximum PASI change from baseline achieved at any time before that visit and analyzed only for the active treatment groups.
Time frame: 37 weeks
Population: The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AIN457 1x25mg | To Assess the Time to Relapse | NA days |
| AIN457 3x25mg | To Assess the Time to Relapse | NA days |
| AIN457 3x75mg | To Assess the Time to Relapse | NA days |
| AIN457 3x150mg | To Assess the Time to Relapse | 203 days |